Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) · 2026
[Application-accompanying performance measurement for Digital Health Applications: Optimisation from a healthcare research perspective for targeted and healthcare-relevant performance measurement].
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Kramer Ursula, Busse Theresa Sophie, Dietzel Nikolas, Heinrich Ria, Kemmerer Pascal, Niemeyer Anna, Richter Jutta G, Singer Susanne, Zeiler Michael, Scheibe Madlen
Аннотация
OBJECTIVE: Digital health applications (DHA) are part of standard care in Germany. With the Digital Act, application-accompanying performance measurement (German: Anwendungsbegleitende Erfolgsmessung, AbEM) will become mandatory in 2026 for evaluating the use and effectiveness of DHA under everyday conditions. The aim of this position paper was to formulate requirements for AbEM that would enable a valid and practice-relevant evaluation. In addition, proposals for the practical implementation of these requirements were developed.
METHODOLOGY: AbEM was discussed and evaluated in 24 meetings of experts from healthcare research, medicine and digital health. Existing concepts for quality measurement and patient-reported outcome and experience measures (PROMs, PREMs) were reviewed and assessed for their transferability. Furthermore, specific requirements for data collection and evaluation in AbEM were identified.
RESULTS: In addition to the proposed measurement instruments for the AbEM, in particular PROMs and PREMs, and the usage data collected within the DHA, reasons for discontinuation and long-term effects as well as undesirable DHA effects should be collected with pre-defined categories. The patient's assessment of the outcomes should be supplemented by an assessment by the therapist at the end of DHA use. Active discontinuation logic in the applications, standardised collection protocols and an electronic patient record interface through which pseudonymised AbEM data is transferred to a common AbEM data pool and evaluated in a DHA-specific and manufacturer-independent manner could increase the knowledge gained from AbEM and its usefulness as a research resource. Comparisons between different DHAs or with treatment alternatives within the framework of AbEM are currently not recommended due to methodological limitations. In the future, inclusion of medical registries that integrate standardised and interoperable DHA master data sets, or the establishment of independent DHA registries, could improve the usability and knowledge gains of AbEM data from DHA.
CONCLUSIONS: AbEM offers the opportunity to make DHA use transparent and promote quality-oriented remuneration. This requires methodologically sound, independent and interoperable data collection that focuses on patient-relevant outcomes, incorporates the perspective of prescribers and enables the integration of (routine) data. The current implementation of DHA-AbEM does not yet sufficiently address these key points.
METHODOLOGY: AbEM was discussed and evaluated in 24 meetings of experts from healthcare research, medicine and digital health. Existing concepts for quality measurement and patient-reported outcome and experience measures (PROMs, PREMs) were reviewed and assessed for their transferability. Furthermore, specific requirements for data collection and evaluation in AbEM were identified.
RESULTS: In addition to the proposed measurement instruments for the AbEM, in particular PROMs and PREMs, and the usage data collected within the DHA, reasons for discontinuation and long-term effects as well as undesirable DHA effects should be collected with pre-defined categories. The patient's assessment of the outcomes should be supplemented by an assessment by the therapist at the end of DHA use. Active discontinuation logic in the applications, standardised collection protocols and an electronic patient record interface through which pseudonymised AbEM data is transferred to a common AbEM data pool and evaluated in a DHA-specific and manufacturer-independent manner could increase the knowledge gained from AbEM and its usefulness as a research resource. Comparisons between different DHAs or with treatment alternatives within the framework of AbEM are currently not recommended due to methodological limitations. In the future, inclusion of medical registries that integrate standardised and interoperable DHA master data sets, or the establishment of independent DHA registries, could improve the usability and knowledge gains of AbEM data from DHA.
CONCLUSIONS: AbEM offers the opportunity to make DHA use transparent and promote quality-oriented remuneration. This requires methodologically sound, independent and interoperable data collection that focuses on patient-relevant outcomes, incorporates the perspective of prescribers and enables the integration of (routine) data. The current implementation of DHA-AbEM does not yet sufficiently address these key points.